BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPT

    MDR report key: 14206738 · Received April 25, 2022

    Report

    Report Number
    MW5109350
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 1, 2022
    Report Date
    April 21, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OYU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A POSITIVE SCREEN ON MY NIPT FOR TRISOMY 21. CHOSE TO DO INVASIVE TESTING, WHICH PROVED TO BE INACCURATE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970879 NIPT DNA-PROBE KIT, HUMAN CHROMOSOME OYU ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other PRENATAL VITAMINS